Ultrasound, Hyperthermia, Cancer Treatment

Product Code: LSY

Ultrasonic Medical Devices (Miscellaneous)

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations:


Radiation TypeAcoustic
Radition SafetyNone
Annual ReportsNo

Products Classified as LSY

5437Ultrasound, Hyperthermia, Cancer Treatment

Total Product Life Cycle (TPLC) Devices

5437Ultrasound, Hyperthermia, Cancer Treatment

FDA Consensus Standards

Ultrasound, Hyperthermia, Cancer Treatment [32412]21 CFR Unclassified 🔎

Pre-market Approvals for LSY

P040003EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEMINSIGHTEC, LTD

Global Unique Device Identification Database

07290015461429Ultrasound,Hyperthermia, Cancer Treatment
07290015461405Ultrasound,Hyperthermia, Cancer Treatment
07290015461337Ultrasound,Hyperthermia, Cancer Treatment
07290015461320Ultrasound,Hyperthermia, Cancer Treatment
07290015461313Ultrasound,Hyperthermia, Cancer Treatment
07290015461306Ultrasound,Hyperthermia, Cancer Treatment
07290015461290Ultrasound,Hyperthermia, Cancer Treatment
07290015461283Ultrasound,Hyperthermia, Cancer Treatment
07290015461276Ultrasound,Hyperthermia, Cancer Treatment
07290015461269Ultrasound,Hyperthermia, Cancer Treatment
07290015461252Ultrasound,Hyperthermia, Cancer Treatment
07290015461245Ultrasound,Hyperthermia, Cancer Treatment
07290015461238Ultrasound,Hyperthermia, Cancer Treatment
07290015461221Ultrasound,Hyperthermia, Cancer Treatment
07290015461214Ultrasound,Hyperthermia, Cancer Treatment

Maude Adverse Events

EXABLATE NEUROINSIGHTEC HAIFA ISRAEL, INSIGHTEC, LTD.2018-05-02

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